
Synergetics
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Spetzler Malis Dual Illuminating Bipolar Forceps is an FDA 510(k)-cleared medical device (K160103) manufactured by Synergetics. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 2016. Regulation: 8.